Identity
- Trade Name
- MOGEN CIRCUMCISION CLAMP FDA UDI
- Generic Name
- Surgical penis clamp, reusable FDA UDI
- Device Name
- MOGEN CIRCUMCISION CLAMP FDA UDI
- Model / Reference
- 540-374 FDA UDI
- Description
- MOGEN CIRCUMCISION CLAMP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896001558 FDA UDI
- 510(k) Number
- K040052 FDA UDI
- FDA Product Code
- HFX FDA UDI
- GMDN Term
- Surgical penis clamp, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Inch FDA UDI
Category: Surgical penis clamp, reusable
Mogen Circumcision Clamp by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical penis clamp, reusable.
- GEN2 — SURGIX MEDICAL LLC · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- AESCULAP — AESCULAP, INC. · Class II
- No-Scalpel Vasectomy — Femcare , Ltd. · Class I
Cleared under the same submission
K040052 also covers:
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC.
- Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 622c7333-7245-4ffd-8987-136a844164fd 36 fields · synced May 30, 2026